Potasion 600 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Potasion 600 mg hard capsules

Potassium chloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Potasion capsules are and what they are used for
2. What you need to know before taking Potasion capsules
3. How to take Potasion capsules
4. Possible side effects
5. How to store Potasion capsules
6. Contents of the pack and other information

1. What Potasion capsules are and what they are used for

Potasion is a mineral supplement.

Potasion is used for the treatment of hypokalaemia (low levels of potassium) in situations such as:

• potassium loss caused by treatment with other medicines such as diuretics (used to increase urine elimination), corticoids, and laxatives,
• potassium loss caused by gastrointestinal disorders (diarrhoea, vomiting), renal problems, or hyperaldosteronism (a condition in which there is an increase in the hormone called aldosterone) with normal kidney function.

Potasion is also used for:

• treatment of poisoning with certain medicines called digitalis (used for heart conditions),
• treatment of familial hypokalemic periodic paralysis (a rare inherited disease causing episodes of severe muscle weakness associated with low blood potassium levels),
• post-surgical care when there is a deficit in potassium intake.

2. What you need to know before starting to take Potasion capsules

Do not take Potasion capsules

• If you are allergic (hypersensitive) to potassium chloride or to any of the other components of Potasion.
• If, after a blood test, your doctor has told you that you have hyperkalemia (high levels of potassium in the blood).
• If you have any condition that hinders or prevents gastrointestinal transit (passage of food through the digestive system), such as intestinal obstruction, narrowing of the digestive tract, or paralytic ileus (intestinal blockage).
• If you have peptic ulcer (ulcer located in the stomach or in the first part of the small intestine called the duodenum) or gastrointestinal bleeding (blood loss originating anywhere in the digestive tract).
• If you have renal insufficiency (kidney problems).
• If you have oliguria or anuria (kidney disease in which you urinate very little or not at all).
• If you have Addison's disease (a disorder that occurs when the adrenal glands do not produce enough of their hormones).

Take special care with Potasion capsules

• If you have diseases that predispose to hyperkalemia (increased levels of potassium in the blood), such as kidney problems, acute dehydration, or destruction of skin tissue as occurs in severe burns.
• If you are being treated with potassium-sparing diuretics (medications to reduce fluid in the body) or with digitalis. Before starting treatment with Potasion, your doctor will order blood tests to monitor how well your kidneys are functioning.
• If you have heart disease (heart or circulatory system disorders) or kidney problems. Regular monitoring of blood potassium levels and periodic electrocardiogram checks are advised.
• If you are over 65 years of age. Your doctor will recommend blood tests to monitor your blood potassium levels.
• If you have previously had a peptic ulcer.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Consult your doctor if you are taking any of the following medicines:

• potassium-sparing diuretics (amiloride, spironolactone, triamterene), angiotensin-converting enzyme inhibitors (ACE inhibitors, used to treat high blood pressure), non-steroidal anti-inflammatory drugs (NSAIDs, used to treat pain and inflammation), β-blockers (used mainly for heart problems), cyclosporine (used in transplant patients), heparin (used to prevent blood clots), and drugs containing potassium. These may promote the accumulation of potassium in the blood,
• laxatives, corticotropin (ACTH, a hormone secreted in the brain), corticosteroids, amphotericin B (an antibiotic used to prevent the growth of certain types of fungi), gentamicin, penicillins, or polymyxin B. These may lead to increased excretion of potassium from the blood,
• sodium exchange ion resins such as sodium polystyrene sulfonate. These resins reduce serum potassium concentrations due to the replacement of potassium by sodium,
• digitalis,
• calcium salts,
• insulin (used to control blood sugar levels),
• bicarbonate,
• quinidine (used to treat heart problems),
• vitamin B12,
• antimuscarinics (delay gastric emptying).

Interference with laboratory tests

If you are due to have any diagnostic tests (including blood and urine tests, reagent strip tests, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Taking Potasion capsules with food and drink

You should not season food with low-sodium salt substitutes containing potassium.

Use in people over 65 years of age

Do not use in people over 65 years of age without consulting a doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant before taking this medicine. In pregnant women, high doses are not recommended.

Administration of this medicine in pregnant women should only occur when recommended by a doctor, as gastrointestinal transit may be delayed.

During breastfeeding, administration of this medicine at high doses is not recommended.

Driving and using machines

No cases have been reported in which Potasion has affected the ability to drive or use machines.

3. How to take Potasion capsules

Follow exactly the administration instructions for Potasion provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

You should take this medicine with food or immediately after a meal.

The contents of Potasion capsules may be crushed, chewed, or sprinkled onto a spoonful of soft food if the patient is unable to swallow the capsule whole.

The usual dose is:

• for preventive treatment: 2–3 capsules daily, in 2–3 divided doses,
• for curative treatment: 5–12 capsules daily, in 2–3 divided doses.

If you take more Potasion capsules than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

It is recommended to bring the medicine package and leaflet to the healthcare professional.

Go immediately to a hospital for symptomatic treatment.

If you forget to take Potasion capsules

Take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time.

Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, Potasion may cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed with unknown frequency (cannot be estimated due to lack of data):

Disorders of metabolism and nutrition

Hyperkalaemia (increased blood potassium levels): may occur if this medicine is administered in excess, especially in patients with kidney problems. To correct a mild increase occurring during prolonged treatment, it may be sufficient to interrupt the intake of this medicine and other drugs that may cause such an increase, as well as to avoid foods high in potassium.

In case of a marked increase in blood potassium, symptoms may include paresthesia of the extremities (tingling in hands or feet), muscle weakness, paralysis, cardiac arrhythmias (irregular heart rhythm), atrioventricular block (a heart condition related to the conduction of electrical impulses), cardiac arrest, and mental confusion.

Gastrointestinal disorders

Occasionally, irritation of the stomach and intestinal mucosa may occur, resulting in nausea, vomiting, diarrhoea, or cramps after taking the medicine. To reduce the occurrence of these adverse effects, it is recommended to take this medicine with meals or immediately after meals.

The microencapsulated formulation of this medicine reduces the risk of ulceration that might occur during treatment with other potassium chloride-containing products.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Potasion capsules

Keep out of the reach and sight of children.

Do not use Potasion after the expiry date shown on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Potasion capsules

• The active substance is potassium chloride. Each hard capsule contains 600 mg of potassium chloride.
• The other components are: ethylcellulose, talc, gelatin, and titanium dioxide.

Appearance of the product and contents of the pack

Potasion capsules are opaque white hard capsules. They are presented in PVC/aluminum blisters. Each package contains 60 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

DESMA Laboratorio Farmacéutico SL
Paseo de la Castellana 121, Escalera Izquierda 3ºB
28046 Madrid
Spain

Manufacturer

Famar Health Care Services Madrid, S.A.U.
Avda. de Leganés, 62
28923 Alcorcón (Madrid)
Spain

and

Laboratorio Farmaceutico SIT S.r.l.
Via Camillo Benso Conte Di Cavour 70
27035 Mede (PV)
Italy

Date of the most recent review of this summary: July 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/